On May 9, 2019 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2019 (Press release, Cytokinetics, MAY 9, 2019, View Source [SID1234536034]). Net loss for the first quarter was $29.4 million, or $0.54 per share, compared to net loss for the first quarter of 2018 of $30.3 million, or $0.56 per share. Cash, cash equivalents and investments totaled $176.6 million at March 31, 2019.

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"We are pleased with the progress made across our pipeline of muscle-directed investigational medicines during the first quarter of 2019," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Recently, we shared encouraging data from FORTITUDE-ALS demonstrating consistency of effect for doses, endpoints and timepoints in patients treated with reldesemtiv and we believe the results may support progression to further clinical trials toward potential registration. We also passed through the first planned interim analysis of GALACTIC-HF and opened enrollment in METEORIC-HF while we also independently continued the conduct of the Phase 1 study of CK-274 and prepared for potential progression to Phase 2. Our strategy to advance multiple drug candidates, under our collaborations and independently, continues to generate upside potential for patients and shareholders."

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Continued conduct of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, following first planned interim analysis for futility. We expect screening in this event-driven trial to complete in the second quarter of 2019.

Opened METEORIC-HF, (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil, to enrollment. METEORIC-HF is a randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. We expect to continue enrollment of METEORIC-HF throughout 2019.

John Teerlink, M.D., Professor of Clinical Medicine, University of California San Francisco and Director of Heart Failure, San Francisco Veterans Affairs Medical Center, presented additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) at the American College of Cardiology’s 68th Annual Scientific Session. The results of a post hoc subgroup analysis of the COSMIC-HF data showed that, between 32 patients with atrial fibrillation (AF) and 117 patients without AF, there were no statistically significant differences in the effects of treatment with omecamtiv mecarbil on cardiac function, including systolic ejection time and stroke volume, as well as ventricular volumes, heart rate, and NT-proBNP.
AMG 594 (cardiac troponin activator)

Continued conduct of the Phase 1 study of AMG 594 to assess its safety, tolerability, pharmacokinetics and potential to increase cardiac function in healthy volunteers. AMG 594 is a novel, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. This Phase 1 study is being conducted by Amgen in collaboration with Cytokinetics. We expect the conduct of this study to continue throughout 2019.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued conduct of the Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-274 in healthy adult subjects. CK-274 is a wholly-owned, novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM). We expect results from this study in the third quarter of 2019 and are preparing for potential progression of CK-274 to Phase 2 in the second half of 2019.
Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Results from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS), were presented during a platform presentation at the American Academy of Neurology 71st Annual Meeting in Philadelphia on Sunday, May 5, 2019.

FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). Similar analyses of ALSFRS-R and slope of the Muscle Strength Mega-Score yielded p values of 0.09 and 0.31, respectively. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, patients who received reldesemtiv in FORTITUDE-ALS declined less than patients who received placebo. The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints. The differences between reldesemtiv and placebo in SVC and ALSFRS-R total score observed after 12 weeks of treatment were still evident at follow-up, four weeks after the last dose of study drug.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA), under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; Astellas is sponsoring Cytokinetics’ activities through 2019.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

Joined the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day, an international campaign elevating the public understanding of rare diseases.
Financials

Revenues for the first quarter of 2019 increased to $8.5 million from $5.3 million for the first quarter of 2018, primarily due to increased research and development revenues from our collaborations with Astellas and Amgen. License revenues in the first quarter of 2018 were related to the Phase 2 study of reldesemtiv in spinal muscle atrophy completed in 2018.

Research and development expenses for the first quarter of 2019 increased to $23.5 million from $22.1 million for the first quarter of 2018, primarily due to increased spending related to the opening of METEORIC-HF and development of CK-274, offset in part by reduced spending for reldesemtiv as well as for tirasemtiv, following suspension of development of tirasemtiv in late 2017. General and administrative expenses increased slightly to $9.4 million for the first quarter of 2019 from $9.3 million for the first quarter of 2018.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter 2019 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 4486595.

An archived replay of the webcast will be available via Cytokinetics’ website until May 16, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 4486595 from May 9, 2019 at 7:30 PM Eastern Time until May 16, 2019.